Vitamin D in Colon Cancer or Resectable Liver Metastases
This study is looking into how vitamin D affects colon cancer cells. Researchers believe that when vitamin D binds to a special receptor (VDR) in cancer cells, it might stop them from growing and even cause them to die. You could be eligible if you have stage I, II, or III colon cancer, or stage IV colon cancer with liver metastases that can be removed by surgery. Participants will receive either a high dose of Vitamin D3 or a placebo (an inactive substance) for 14 to 28 days before their surgery. The main goal is to measure how much Vitamin D3 binds to the VDR in your body after this time.
- Study design
- This is an interventional study with a planned enrollment of 80 participants. After an initial run-in phase, participants will be randomly assigned to receive either high-dose Vitamin D3 or a placebo.
- What's involved
- You will take the study drug (Vitamin D3 or placebo) once daily for 14 to 28 days before your surgery. You will also keep a diary to track when you take the study drug.
- Compensation
- Not stated in the trial record.
- Follow-up
- VDR binding sites will be measured between 14 and 28 days after starting the study drug.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT02172651
Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases
Recruiting
EARLY_PHASE1Ages 18+InterventionalBasic scienceDana-Farber Cancer InstituteInvestigator-initiated
~80 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:Vitamin D3Placebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
VDR Binding Sites
Measured over 14 to 28 days
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Kimmie Ng, MD, MPH · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
Kimmie Ng, MD
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must have histologically confirmed adenocarcinoma of the colon that is localized, with no evidence of distant metastasis (stage I, II, or III), and for which surgical resection of the primary tumor is being planned;
OR
Participants must have histologically or cytologically confirmed adenocarcinoma of the colon with resectable liver metastases for which liver resection is being planned.
No prior radiation therapy or systemic treatment is allowed for patients undergoing resection of stage I, II, or III colon cancer.
Prior systemic treatment or radiation therapy is allowed for patients with resectable liver metastases.
The last dose of chemotherapy or radiation must have been administered at least 4 weeks prior to liver surgery.
The last dose of bevacizumab must have been administered at least 6 weeks prior to liver resection.
Age ≥18 years.
ECOG performance status ≤ 1 (see Appendix A)
Participants must have normal organ and marrow function as defined below:
Total bilirubin ≤1.5× institutional upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN, or \<5x ULN if clearly attributable to liver metastases
Serum calcium (corrected for albumin level) ≤ 1x institutional ULN
Serum creatinine within normal institutional limits or creatinine clearance ≥60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
Participants on full-dose anticoagulation are eligible if the following criteria are met:
Participant has an in-range INR (usually 2-3) on a stable dose of warfarin or is on a stable dose of low molecular weight heparin
Participant has no active bleeding or pathological condition that carries a high risk of bleeding (i.e., tumor involving major vessels or known varices)
Participants receiving anti-platelet agents are eligible. In addition, patients who are on daily prophylactic aspirin or anticoagulation for atrial fibrillation are eligible.
Discontinuation of anticoagulation, aspirin, and/or anti-platelet agents prior to surgery will occur according to institutional standards of care.
Non-pregnant and not nursing
Women of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 14 days prior to study entry. Women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥12 consecutive months; or women on hormone replacement therapy with documented serum follicle stimulating hormone level \>35 mIU/mL). Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child-bearing potential.
The effects of higher-dose vitamin D3 and colon or liver surgery (and associated perioperative medications and anesthesia) on the developing human fetus are unknown and may pose unacceptable risk. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
Prior systemic therapy, radiotherapy, or investigational agent in participants undergoing surgery for stage I, II, or III colon cancer.
Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for bevacizumab) of liver resection.
Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.
Inability to swallow pills.
History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease significantly affecting gastrointestinal function that could interfere with absorption of oral medications.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to vitamin D.
Regular use of supplemental vitamin D totaling ≥ 2,000 IU/day in the past year.
Use of supplemental vitamin D or supplements containing vitamin D beyond the protocol-prescribed study treatment is not allowed during the treatment period of this clinical trial.
In order to maintain blinding, vitamin D levels should not be routinely checked at screening or during the study by the treating investigator. Vitamin D levels will be assayed only as part of the research blood samples collected during the study. If there are concerns related to a participant's vitamin D status, the lead Principal Investigator should be contacted for further discussion.
Use of chronic oral corticosteroid therapy, lithium, phenytoin, quinidine, isoniazid, and/or rifampin (all of which can cause vitamin D depletion). Short-term use of corticosteroids as anti-emetic therapy for chemotherapy is permitted.
Regular use of thiazide diuretics (i.e., hydrochlorothiazide), which can lead to hypercalcemia, and unwillingness or inability to discontinue or switch to an alternative anti-hypertensive agent.
Pre-existing hypercalcemia (defined as baseline serum calcium above the institutional ULN, corrected for albumin level if albumin is not within institutional limits of normal).
Known active hyperparathyroid disease or other serious disturbance of calcium metabolism in the past 5 years.
History of symptomatic genitourinary stones within the past year.
Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results.
Pregnant or nursing women or men/women of child-bearing potential who are unwilling to employ adequate contraception.
History of prior or synchronous malignancy except:
A malignancy that was treated with curative intent, for which there has been no known active disease for \>3 years prior to randomization, and for which the risk of recurrence is low as determined by the investigator.
Curatively treated non-melanoma skin malignancy, cervical cancer in situ, or prostatic intraepithelial neoplasia without evidence of prostate cancer.
Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
Participants with these infections are ineligible because they are at increased risk of significant complications in the perioperative period, particularly for active hepatitis B or C patients undergoing liver resection. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
What this trial measures
- VDR Binding Sites14 to 28 days
For patients undergoing primary colon resection, the goal is to identify VDR binding sites in malignant and normal colonic tissue collected from colon cancer patients treated with high-dose vitamin D3 versus placebo. ChIP-Seq will be performed on frozen tumor tissue and adjacent normal colon tissue to determine VDR binding sites, which will be compared between the high-dose vitamin D and placebo arms, and between malignant tumor and normal colon tissue.